Thermal material nebulizing system

ABSTRACT

A system for thermal regulation of a nebulizer is provided. The system includes a container to house a nebulizer and a thermal material together. The thermal material acts to chill a liquid located inside the nebulizer in order to deliver a chilled mist to a patient for therapeutic purposes, such as initiating therapeutic hypothermia, or treating various respiratory illnesses such as croup, laryngobronchitis, and smoke inhalation.

BACKGROUND Technical Field

The present disclosure relates to devices for atomizing liquid and, moreparticularly, to a noninvasive portable apparatus and system thatutilizes a thermal medium to chill atomized liquid into a stream ofchilled mist during nebulization.

Description of the Related Art

Nebulizers are commonly found in the healthcare industry for delivery ofatomized mist to a patient. Nebulizers hold a prescribed amount ofliquid medication or saline that is then atomized for inhalation. Themedication used will vary, depending on the needs of the patient, whichcan range from Albuterol for Asthma to Racemic Epinephrine for Croup.Nebulizers utilize a variety of technologies to atomize the solutionsbeing inhaled, such as jet nebulizers, High Density Jet Nebulizers,ultrasonic wave nebulizers, and ultrasonic vibrating mesh technologyamong others. These methods all produce a room temperature mistdelivered to the patient's airway, usually particles fewer than 5micrometers for better delivery to the patient's airway.

Nebulizers are used for a variety of conditions including but notlimited to Croup, RSV, Epiglottitis, Allergic Reactions, Bronchospasm,Laryngitis, Pneumonia, Asthma, COPD, Bronchitis, Sepsis, ventilatedpatients, and smoke/heat/blast inhalation patients. They are commonlyused by Emergency Medical Services (EMS) Pre-Hospital, ambulance,medical flight crews in aircraft, in Emergency Departments, ICU's,CCU's, Operating rooms, Recovery rooms, Medical and Surgical units,Respiratory Therapy for both in and out patients, Medical Short Stayunits, doctors' offices, urgent care clinics, Home Health, MilitaryMedical personal in military hospitals, field hospitals, and front linemedic treatment, Wilderness expedition medical crews, World OutreachMedical Teams, individual patients in their homes and by Veterinariansin Animal Hospitals, Zoos, Clinics, and in Outpatient settings.

Chilled liquid nebulized into mist can have beneficial effects on thepatient and can be more comfortable for the patient. Chilled liquidnebulized into mist can act to reduce swelling and irritation of thelarynx and upper respiratory tract due to illness such as croup,bronchitis, allergic reaction, smoke inhalation and other airwaycompromised patients. Chilled liquid nebulized into mist can act toinitiate Therapeutic Hypothermia and treat other heat related illness.

Attempts have been made to chill breathable gases in the past, forexample those of U.S. Pat. No. 6,536,423 (“Conway”), U.S. Pat. No.6,997,184 (“Donohue”), U.S. Pat. No. 7,201,163 (“Jiang et al”) and U.S.patent application Ser. No. 11/899,110 (“Carrier”). However, theseattempts have all failed to produce an adaptable, ergonomic, highlyportable, simple way to produce chilled mist nebulized from chilledliquid. For example, Conway uses a complicated mist producing apparatusthat requires a constant power supply and is not compatible withstandard nebulizers. Donohue cannot interface with a nebulizer and,therefore, cannot chill the fine mist produced by a nebulizer.Furthermore, Donohue chills the air that is breathed in immediatelyprior to breathing in, which may cause significant condensation of anyfine particles contained in the air, significantly reducing the benefitsof breathing fine particles. Similarly, Jiang et al uses a complex heatexchanger in order to chill or heat the mist and is not compatible withstandard nebulizers in a portable manner. Carrier also does notinterface with a standard nebulizer, and his device produces thechilling effect immediately prior to inhalation, which can cause thecondensation issues described above. Carrier also involves a number ofseparate pieces that must be placed together in order to use the device,greatly reducing simplicity and ease of use.

Moreover, these designs require complicated processes and setups, andnone are readily compatible with standard small-volume nebulizers,therefore requiring additional costly devices. There is a need,therefore, for a simple, ergonomic solution to chill the nebulized mistcoming from a standard nebulizer, without requiring expensive orcomplicated systems. Such a solution should address the need for rapidreduction of airway edema, irritation, and/or inflammation in patientswith Epiglottis, Croup, RSV, Bronchospasm, Fever, Allergic Reaction,Smoke Inhalation, Blast Injury, Asthma, Bronchitis, Pneumonia,Laryngitis, Sepsis, COPD, ventilated patients, and pre and post ENTsurgery, as well as provide for core cooling during CPR. Moreover, thereis a need for rapid initiation of Therapeutic Hypothermia for patientspost Cardiac Arrest or acute brain insult. Furthermore, there is a needfor Targeted Temperature Management (TTM).

BRIEF SUMMARY

In accordance with one embodiment of the present disclosure, a thermalnebulizing system is disclosed. The thermal nebulizing system includes adevice that has a container with an interior, an input port in fluidcommunication with the interior, a nebulizer in the interior of thecontainer and coupled to the input port, a conduit coupled to thenebulizer and configured to deliver a mist from the nebulizer to theexterior of the container, and a lid configured to cover the container.The interior is configured to accept a thermal material for cooling.

In another embodiment, the device has a thermal material configured tochill a liquid; a source configured to deliver at least one of oxygen orcompressed air to the nebulizer; and a delivery mechanism configured tointerface with a recipient and deliver chilled nebulized mist from thenebulizer to the recipient. In a further embodiment, the thermalmaterial is an evaporative material.

In accordance with one aspect of the present disclosure, a device isprovided that includes a container having at least a side wall and abottom wall configured to define an open interior and an open top incommunication with the interior, and an input port in the bottom wall orthe side wall that is in fluid communication with the interior; anebulizer located in the interior of the container and coupled to theinput port for fluid communication; a lid configured to cover the opentop and provide fluid communication with the interior of the container;and a conduit coupled to the lid and the nebulizer and configured todeliver a chilled mist from the nebulizer through the access tubeextending through the lid to an exterior of the container.

In accordance with another aspect of the present disclosure, the deviceincludes a nipple extending through the container input port and intothe interior of the container, the nipple coupled to an input of thenebulizer and sized and shaped to provide fluid communication betweenthe input port and the input of the nebulizer and to position thenebulizer above the bottom wall of the container.

In accordance with a further aspect of the present disclosure, thedevice includes a delivery apparatus coupled to the conduit thatincludes a mask having a body with an interior chamber and a cap withradially oriented flaps that are capable of bending inward into theinterior chamber, the interior chamber sized and shaped to accommodatethe muzzle, snout or beak of an animal.

In accordance with still yet another aspect of the present disclosure, asystem is provided that includes a thermal material configured to chilla liquid; a nebulizing device; a hand-holdable container having aninterior sized and shaped to receive the nebulizing device andconfigured to store the thermal material around the nebulizing device; asource configured to deliver at least one of oxygen or compressed air toan input of the nebulizing device; and a delivery apparatus operablycoupled to an output of the nebulizing device and configured tointerface with a recipient and deliver chilled nebulized mist from thenebulizing device to the recipient.

Ideally, the system includes a conduit extending through the containerand into the interior of the container, the conduit coupled to the inputof the nebulizing device and sized and shaped to provide fluidcommunication between the source and the input of the nebulizing deviceand to hold the nebulizing device above the bottom wall of thecontainer.

In accordance with still yet a further aspect of the present disclosure,a thermal material nebulizing and delivery apparatus is provided thatincludes a nebulizer having a fluid input and a fluid output andconfigured to hold a liquid; thermal material; a container configured tohold the thermal material and the nebulizer, the container having aninterior and an input port and an open top in fluid communication withthe interior and the input port; a cover configured to close the opentop and having an opening structured to provide fluid communication withthe interior; and a conduit mounted in the opening of the cover andcoupled to the nebulizer and configured to deliver a chilled mist fromthe nebulizer through the lid and to an exterior of the container.

Ideally, the apparatus includes a conduit extending through thecontainer and into the interior of the container, the conduit coupled tothe input of the nebulizing device and sized and shaped to provide fluidcommunication between the source and the input of the nebulizing deviceand to hold the nebulizing device above the bottom wall of thecontainer.

In accordance with a further aspect of the present disclosure, thecontainer is configured to hold the nebulizer in the interior and thecontainer is configured to hold the thermal evaporative material in theinterior surrounding the contained nebulizer. Alternatively, thecontainer includes a double-walled portion having an interior spaceconfigured to hold the thermal material.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing and other features and advantages of the presentdisclosure will be more readily appreciated as the same become betterunderstood from the following detailed description when taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is an isometric view of a thermal nebulizing device that includesa delivery mechanism according to one embodiment of the presentdisclosure;

FIG. 2 is a partially exploded isometric view of the device of FIG. 1;

FIG. 3 is an isometric view of a container and cap of the device of FIG.1;

FIG. 4 is an isometric view of a thermal nebulizing device that includesa mouthpiece attached to a connector according to one embodiment of thepresent disclosure;

FIG. 5 is a partially exploded isometric view of the nebulizing deviceof FIG. 4;

FIG. 6 is a partially exploded isometric view of a thermal nebulizingdevice with handles according to one embodiment of the presentdisclosure;

FIG. 7 is an isometric view of a thermal nebulizing device utilizing athermal evaporative material according to one embodiment of the presentdisclosure;

FIG. 8 is an isometric view of a thermal nebulizing device that includesa mask configured to be used with animals or birds according to oneembodiment of the present disclosure;

FIG. 9 is an isometric view of the nebulizing device of FIG. 8illustrating an animal using the nebulizing device;

FIG. 10 is an isometric view of a mask being used with an animalaccording to one embodiment of the present disclosure;

FIG. 11 is an enlarged isometric view of the mask of FIG. 10;

FIG. 12 is an isometric view of a thermal nebulizing device thatincludes a mask to attach to a recipient's face according to oneembodiment of the present disclosure;

FIG. 13 is a partially exploded view of the nebulizing device of FIG.12;

FIG. 14 is an isometric view of the nebulizing device of FIG. 12 shownbeing used by a child;

FIG. 15 is an isometric view of a thermal nebulizing device with apacifier mist delivery device according to one embodiment of the presentdisclosure;

FIG. 16 is an isometric view of a thermal nebulizing device having adual port T-connector and supply tubing according to one embodiment ofthe present disclosure;

FIG. 17 is an isometric view of the nebulizing device of FIG. 16illustrating a dual-port embodiment in which one end of the T-connectoris blocked off according to one embodiment of the present disclosure;

FIG. 18 is a chart illustrating five mist cooling configurations for theThermal Nebulizing System;

FIG. 19 is an pictorial view illustrating a doubled wall configurationof the thermal nebulizing container in accordance with another aspect ofthe present disclosure; and

FIG. 20 is a partial cut-away isometric view illustrating the doubledwall configuration of the thermal nebulizing container of FIG. 19.

DETAILED DESCRIPTION

In the following description, certain specific details are set forth inorder to provide a thorough understanding of various disclosedembodiments. However, one skilled in the relevant art will recognizethat embodiments may be practiced without one or more of these specificdetails, or with other methods, components, materials, etc. In otherinstances, well-known structures or components or both associated withthe nebulizing system, including but not limited to the oxygen or aircompressor have not been shown or described in order to avoidunnecessarily obscuring descriptions of the embodiments.

Unless the context requires otherwise, throughout the specification andclaims that follow, the word “comprise” and variations thereof, such as“comprises” and “comprising” are to be construed in an open inclusivesense, that is, as “including, but not limited to.” The foregoingapplies equally to the words “including” and “having.”

Reference throughout this description to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, the appearance of the phrases “in oneembodiment” or “in an embodiment” in various places throughout thespecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments.

FIG. 1 shows a thermal nebulizing apparatus 20 configured to produce achilled atomized mist to a patient for therapeutic purposes. The thermalnebulizing system 20 includes a container 22, a lid 24 removablyattached to the container, thermal material 26 (shown in FIG. 7) in aninterior 44 of the container 22 along with a nebulizer 28, and adelivery mechanism 30. The apparatus 20 also includes a T-shapedconnector 32 mounted on top of an access tube 52, and a mist deliverytube 34 configured to be coupled to the connector 32. The thermalnebulizing system 20 provides a number of benefits to patients throughthe use of the container 22 and thermal material 26. The thermalmaterial 26 acts to cool a liquid 38 that is located in the nebulizer28, thereby delivering a chilled mist to the patient after nebulization.

Referring to FIGS. 1 through 3, the container 22 is made up of acircular sidewall 40 and a bottom 42, forming a substantially hollowinterior 44, which is accessible through an opening 46 in the containertop. The interior 44 is configured to receive and house the nebulizer28.

In addition, the interior 44 is structured to receive and store thethermal material 26. The bottom 42 of the container 22 has a connectornipple 48 extending from the interior 44 through to the exterior of thebottom 42, which is structured to provide fluid communication between aninterior 45 of the nebulizer 28 and the outside of the container 22. Inother embodiments the connector nipple 48 may be located so as to extendthrough the sidewall 40 of the container 22, or any other suitablelocation to provide fluid communication between the nebulizer interior45 and the exterior of the container 22. In some embodiments, theconnector nipple 48 may be inserted through and sealingly connected tothe container 22 through a snug fitting; however, the nipple 48 may bealso be sealingly connected using an adhesive, threading or any othersuitable means that provides a seal between the nipple 48 and thecontainer 22 in order to prevent air or liquid from leaking to theoutside of the container 22. The ideal embodiment would be injectionmolded with the nebulizer 28 a fluid part of the container 22 housed inthe interior 44 accessed through the opening 46 at the top of thecontainer 22. The access tube 52 is formed to be in fluid communicationwith the nebulizer 28.

The lid 24 is mounted on to the container 22 in order to close off theopening 46. The lid 24 may be any shape or size, but preferably has atwo-tiered convex dome configuration 49. The lid 24 is structured tomount to the sidewall 40 of the container to remain firmly in place yetbe removable. The lid 24 may attach to the sidewall 40 through ascrew-type threading, or it may snap onto the container 22 using ribs ordepressions on the lid 24 and sidewall 40 or by any other suitablemeans.

The lid 24 includes a tube opening 50 in the top of the dome toaccommodate an extension tube or access tube 52, which is configured toprovide fluid communication between the nebulizer 28 and the connector32. The tube opening 50 in the lid 24 has a generally circular shapethrough which the access tube 52 can be inserted. However, in otherembodiments, the tube opening 50 can be any shape and size suitable toaccommodate the access tube 52. The access tube 52 is connected to theoutput of the nebulizer 28 for fluid communication, and it is configuredas the output conduit of the nebulizer 28 through which the atomizedmist is conveyed and expelled. The access tube 52 is formed to projectthrough the tube opening 50 and connect to a fitting 31 on the connector32, preferably in a slidable arrangement. The lid 24 with the tubeopening 50 and access tube 52 therefore enable fluid communicationbetween the output of the nebulizer 28 and the connector 32 while stillclosing off the opening 46 of the container 22 to any other fluidcommunication.

The thermal material 26 (shown in FIG. 7) can be any material withthermal properties capable of inducing a cooling effect on the liquid 38in the nebulizer 28. The thermal material 26 may induce a cooling effecton the liquid 38. For example, in some cases, a patient may requireTherapeutic Hypothermia, in order to cool the temperature of thepatient's body. In such a case, the thermal material 26 would be of atype to cool the liquid 38 in order to deliver a chilled mist to thepatient. The thermal material 26 is stored in the interior 44 of thecontainer 22, where it thermally interacts with the liquid 38 in thenebulizer 28 in order to induce a cooling effect.

The nebulizer 28 is generally a small volume nebulizer, structured to beinserted into the interior 44 of the container 22. Because the nebulizer28 is readily commercially available, it will not be described in detailherein. Briefly, the nebulizer 28 can be any type of nebulizer, forexample, an ultrasonic nebulizer, jet nebulizer, High Density JetNebulizer or vibrating mesh nebulizer, but is preferably a small volumejet nebulizer, such as those manufactured by CareFusion. Generally, thenebulizer 28 has a housing 29 that defines the interior space 45.Typically, the housing 28 is formed of a top 31 and a bottom 33 with afluid input 35 formed in the bottom 33, which is in fluid communicationwith the interior space 45, and a fluid output 37 formed in the top 31,which is also in fluid communication with the nebulizer interior space45. The interior space 45 of the nebulizer 28 contains the liquid 38,which is reduced to a mist of fine particles and delivered to thepatient through the fluid output 37 of the nebulizer and the access tube52. In all embodiments, the interior space 45 of the nebulizer 28 is influid communication with the connector nipple 48. In such an embodiment,the nebulizer 28 receives a gaseous input from a gas source through theconnector nipple 48, for example, compressed air or oxygen.

As seen in FIGS. 1 and 2, the nipple 48 extends into the interior 44 ofthe container 22 a short distance before coupling to the input on thebottom of the nebulizer 28. This positions the nebulizer 28 above thecontainer bottom 48 to be centrally disposed inside the interior 44 ofthe container 22, permitting the coolant or thermal material to surroundthe nebulizer 28 from the bottom 33 to the top 31 thereof. Thisfacilitates more rapid and complete cooling of the liquid 38 in thenebulizer 48 as described more fully below.

The delivery mechanism 30 is an interface through which a patientreceives the therapeutic mist from the thermal nebulizing system 20. Thedelivery mechanism 30 is in fluid communication with the nebulizer 28through the connector 32, either directly or through the tube 34, wherethe tube is connected to the connector 32 on one end and the deliverymechanism 30 on the other end. In other embodiments, the deliverymechanism may connect directly to the access tube 52. The deliverymechanism 30 is configured to enable a patient to receive the chilledatomized mist through the delivery mechanism 30. There are a number ofdelivery mechanisms commercially available, such as masks, mouthpieces,endotracheal tubes and pacifier mist delivery devices, and these willnot be described in more detail.

The connector 32 is generally a T-shaped connector, but could also beany other connector with two or more end openings, such as an L-shapedconnector, a straight tube connector, or a Y-shaped connector. Theconnector 32 has generally a hollow cylindrical shape, but it could alsobe any other shape. The fitting 31 extends at substantially a rightangle from a cross tube 33, and both the fitting 31 and the cross tube33 are substantially hollow to allow for air passage. The fitting 31 isstructured to connect the access tube 52 to the cross tube 33 andultimately to the delivery mechanism 30 via the flexible tube 34. Theconnector 32 may also optionally include a cover 36 in order to closeoff one of the cross tube 33 openings.

In the partially exploded view of FIG. 2, the thermal nebulizing system20 is assembled by placing the nebulizer 28 inside the container 22,placing the thermal material 26 inside the container 22 (as shown inFIG. 7), and placing the lid 24 on the container 22 to cover the opening46 while positioning the access tube 52 through the tube opening 50. Theconnector 32 is attached to the access tube 52, and the deliverymechanism 30 is attached to a connector, to attach to a ventilator. Thecontainer 22 may optionally also be covered in a thermally insulatingsleeve in order to decrease loss of cooling ability, such as a neoprenesleeve. The nebulizer 28 is then used regularly, either with a liquidmedication 38 or with sterile saline, while the patient breathes in thechilled mist through the delivery mechanism 30.

FIG. 3 is an exploded view of the container 22 and lid 24. The container22 can be any suitable material, but is preferably a material with aninsulating quality in order to decrease thermal losses. The container 22is generally made of a rigid material, such as plastic, polyethylene orpolycarbonate, in order to protect the nebulizer 28 and thermal material26. Other embodiments may use a flexible material for enhancedportability and storage ability when not in use. In some embodiments,the container is between 1.5 and 4 inches in width or diameter, andbetween 3 and 6 inches in height, preferably about 2.5 inches in widthor diameter and about 4.5 inches in height. The opening 46 is generallyabout the same width as the container 22, or it may be somewhat smallerthan the width of the container. Ideally, a 20 ounce size bottle ispreferred because anything smaller would not hold enough ice along withthe nebulizer 28, and anything much larger would be difficult for achild to hold. The container 22 may be transparent, translucent, oropaque.

The lid 24 is configured to entirely cover and removably attach to thecontainer 22 at the opening 46. The lid 24 may be attached to thecontainer 22 in any suitable fashion, such as threading, rib to ribconnection, rib to depression connection, or any other method. The tubeopening 50 is configured to snugly fit the access tube 52 through thetube opening 50, and it is generally located in the center of the lid24. The tube opening 50 may be of any size suitable to fit the accesstube 52, but is preferably between 0.5 and 1.5 inches.

FIGS. 4 and 5 show the thermal nebulizing system 20 with a corrugatedtube 60 and mouthpiece 62, both of which are readily commerciallyavailable. The embodiment shown in FIG. 4 is the preferred embodimentfor the typical method of use. The corrugated tube 60 is configured toremovably attach to the connector 32, while the mouthpiece 62 attachesto the other end of the connector 32, and is used as the deliverymechanism 30. The corrugated tube 60 allows ambient air to freely mixwith the chilled nebulized mist upon delivery when desired. Thecorrugated tube further allows for the expiration of gases from thethermal nebulizing system 20 when necessary. The mouthpiece 62 is placedinto a patient's mouth, and the nebulized mist, or oxygen enriched mist,is then inhaled by the patient through the mouthpiece. The connector 32may also include an attachment point 64, to which an anchor or tethercan be attached to keep the corrugated tube 60 in a desired position.

FIG. 6 shows the thermal nebulizing system 20 with at least one handle70 attached to the container 22. The handle 70 could be place on bothsides of the container 22, or the container could have only one handle70. The handle could be anything suitable to make gripping the containereasier, such as a D-shaped piece of rigid material. In some embodiments,the handle 70 is removable, being attached through any suitableremovable means, such as a slot/insert mechanism or a hook and loopmechanism, such as Velcro. In other embodiments the handle 70 could bepermanently attached to or formed to be integral with the container 22.

FIG. 7 shows the thermal nebulizing system 20 with the thermal material26, in this case a thermal evaporative material 80 and a tubing 82. Thethermal evaporative material 80 is a fast evaporating material that isplaced in the interior 44 of the container 22 in order to chill theliquid 38. The evaporative material 80 could be any dry material capableof rapid evaporation to provide a cooling effect, such as evaporativematerial available from the Shanghai Tianjin Industry Co., Ltd. Thethermal evaporative material 80 is activated by adding 30-60 mls waterto 12-22 grams of dry snowflake shaped pieces of the evaporativematerial 80. This allows users to chill the liquid 38 without access topower or ice, making the thermal nebulizing system 20 highly portableand mobile. The thermal evaporative material 80 can also be mixed withice if available and desired in order to produce an even greater coolingeffect.

In other embodiments, the thermal material 26 could be any suitablethermal material, such as ice, an ice and water mixture, cold water,frozen Thermal Gel Bead packs or a cold pack, such as the DynarexInstant Cold Pack. In further embodiments, the thermal material 26located inside the interior 44 of the container 22, with the addition ofa thermal material applied to the outside of the container, such as acold pack wrapped around the outside of the container 22 for greatercooling effect. In other embodiments, the container 22 is configured toinclude a thermal material as an integrated part of the sidewall 40,bottom 42, or both in the form of an insulated container 22.

The cooling temperatures of various types of thermal materials 26 usedin conjunction with various delivery mechanisms 30 can be seen in thegraph of FIG. 18. In a controlled environment this device predictablychilled nebulized mist to a Celsius temperature significantly less thanambient temperature for one hour. FIG. 18 compares four types of Thermalmedium for cooling liquid that is nebulized to a chilled mist. Four ofthe five configurations tested remained consistently under 10 degreesCelsius at the eight minute mark until termination of testing. The fifthconfiguration remained under 13 degrees Celsius from the five minutemark until termination of testing. All configurations indicate a slightincrease in temperature when additional fluid was added to continueadequate mist production. The optional disposable insulator is a foilbacked bubble wrap chosen for its lightweight yet effective insulatingproperties. Testing was terminated at one hour as this best reflects thelongest expected transport time for the patient to a hospital or MedicalCenter.

Returning to FIG. 7, the tubing 82 is configured to be connected to theconnector nipple 48 to deliver a gas to the nebulizer 28. The tubing 82connects to the connector nipple 48 in any suitable way, such as snugglyfitting the tubing 82 over the connector nipple 48, snuggly fitting theconnector nipple 48 over the tubing 82, or screwing the tubing 82 andconnector nipple 48 together with a threading system.

As shown in the figures, the container bottom 42 is concave and has aplurality of radially oriented ridges 45. However, the bottom 42 can beformed without the ridges 45 and, in some configurations can be flat.

The tubing can be any size sufficient to deliver the required amount ofgas to the nebulizer 28, but is preferably between ¼ inch and ¾ inch.The tubing 82 is connected to a gas source (not shown) on the oppositeend from the connector nipple 48. The gas source can supply natural air,oxygen, or other suitable compressed gas source. The gas source ispreferably set to deliver gas through the tubing at 8 Liters/minute, butcan be set to any desired level. The tubing can be any length suitableto connect the thermal nebulizing system 20 to the gas source, but ispreferably between 3 feet and 10 feet long.

FIGS. 8-11 show the thermal nebulizing system 20 with an animal mask 90as the delivery mechanism. The animal mask 90 can be used to delivertherapeutic nebulizing techniques to animals 103. The animal mask 90 isconfigured to be placed over the mouth, snout, beak or trunk of ananimal without harming the animal, in order to deliver nebulized mist tothe animal's air passages. The animal mask 90 can be connected directlyto the connector 32, the access tube 52, or it can be connected to theconnector 32 via the flexible tube 34 in order to give greater reach tothe mask 90.

In the illustrated version of FIGS. 8 and 9, the mask 90 has a circularsidewall 92, a removable petal cap 94, and a bottom wall 96 thattogether define an interior chamber 93. The mask 90 also includes anaccess point 98 that is structured as an input port for fluidcommunication with the interior chamber 93. The sidewall 92 can beeither substantially straight, perpendicular to the bottom wall 96 andremovable petal cap 94 or angled with respect to the bottom wall 96 andremovable petal cap 94 to create a tapered sidewall 92. The sidewall 92and bottom wall 96 are preferably made of light weight, rigid materialsuch as plastic, but can also be made of a flexible material in order tofacilitate easier storage and portability. The access point 98 ispreferably located in the bottom wall 96, and is generally a hole in thebottom wall, or a hollow cylinder in the bottom wall 96 through whichthe animal mask 90 is connected to either the connector 32 or the tube34. The access point 98 is of sufficient size to connect to theconnector 32 or the flexible tube 34, either through snug fitting, athreaded screw type connection, or other suitable semi-air tightconnections. Other embodiments of the access point 98 may include anL-shaped cylindrical port for direct connection to the access tube 52 orfor connection to the connector 32 or tube 34.

The removable petal cap 94 attaches to the sidewall 92 of the animalmask 90. The petal cap 94 can be attached through any means, including,without limitation, a slip on fitting, a rib-to-rib snap fitting,rib-to-depression snap fitting, and a screw type fitting. In embodimentswhere the sidewall 92 is made of a flexible material, a rigid connectivepart may be located on the edge of the sidewall 92 in order tofacilitate easier connection between the petal cap 94 and the sidewall92.

The petal cap is made of several flexible flaps that are arcuate-shapedpetals 100, which are connected around the outer edge of the petal cap94 and come together near the center of the petal cap. As shown in FIG.11, the petals 100 are sized and shaped to leave a circular opening 95at the center of the cap 94 that is in fluid communication with theinterior chamber 93.

The petals 100 are radially oriented and designed to bend or flexcentrally inward, flexing along the connected edge, and provide asealable opening about an animal's muzzle, beak or trunk when insertedinto the animal mask 90. When no animal is utilizing the mask 90, thepetals 100 return to a natural state, in which they are positionedroughly perpendicular to the sidewall 92, and abut each other tosubstantially close off the interior of the mask 90. The petals 100allow for a safe, snug fit between the animal mask 90 and an animal,while keeping dust and other contaminants out of the mask 90 while notin use. The sidewall 92 or bottom wall 96, or both, may also contain aseries of holes 102, which are configured to enable ambient air to mixwith the nebulized mist when the animal 103 is using the nebulizingsystem 20 and provide easy exhalation.

The animal mask 90 may also optionally contain handles 104. The handles104 can be either permanently fixed to the mask 90 or removablyattachable to the sidewall 92 through any suitable means, such as aslot/insert mechanism or a hook and look mechanism, such as Velcro.Preferably, the handles are located on the sidewall 92; however, theymay also be located on the bottom wall 96 or petal cap 94. The handlesallow for a user to hold the animal mask 90 more comfortably, steadilyand without obstructing the holes 102.

The animal mask 90 can be made in a variety of sizes and shapes in orderto be used with a variety of animals, as shown in FIG. 10. Animal masks90 that are of similar shape, but different size could be nestedtogether, with smaller masks 90 inside larger masks 90, in order toreduce the storage space necessary and increase portability and mobilityof the masks 90. The mask 90 may also include a strap or resilientfilament connected to the sidewall 92 or elsewhere to aid in holding themask 90 to the animal's head.

FIGS. 12 and 13 show the thermal nebulizing system 20 with an attachedface mask 110 as the delivery mechanism 30. The face mask 110 attachesto the thermal nebulizing system 20 through the connector 32 or mayconnect directly to the access tube 52. The face mask 110 may alsoconnect to either the access tube 52 or connector 32 through the tube 34in order to allow for greater mobility. The face mask 110 is generallyshaped to fit around the mouth and lower face of a patient, and can beheld in place by a flexible, reliant one-piece strap 112. The strap 112connects to the face mask through any suitable means, such as using anadhesive or tying the strap on, and is used to hold the face mask 110 tothe patients face without the need for the patient to perform any taskin order to keep the face mask 110 on the lower face. The mask 110 alsocontains an access or attachment point 116, in order to allow forconnection with the nebulizer 28. The access point 116 may be agenerally circular opening in the face mask, or it can be a straight orbent hollow cylindrical tube located in the mask. The access point 116connects to the nebulizer 28 through the access tube 52, connector 32 ortube 34. The face mask 110 also may contain one or more relief holes 114that allow a patient to exhale normally and ambient air to mix with thenebulized mist. The face mask 110 can be made in a variety of sizes inorder to fit a variety of patients who may require the use of the maskdue to limited ability to use one of the alternate delivery mechanisms30.

FIG. 14 illustrates the thermal nebulizing apparatus 20 of FIG. 12 beingused on a pediatric patient 111. Pediatric patients are often unable toeffectively use many of the alternate delivery mechanisms and,therefore, must utilize the face mask 110 in order to use the thermalnebulizing system 20 for a beneficial amount of time. The patient placesthe face mask 110 on their face and then places the strap 112 behindtheir head in order to hold it in place then breathes normally.Alternately, a caretaker may place the face mask 110 and strap 112 onthe patient if they are unable to do so.

FIG. 15 shows the thermal nebulizing system 20 with an attached pacifiermist delivery device 120. The pacifier mist delivery device 120 isintended for use with pediatric patients 111 in order to ease thetransition into breathing in nebulized mist by using a device familiarto most pediatric patients. The pacifier mist delivery device isgenerally in the shape of a standard pacifier and contains an airchannel that goes the length of the pacifier to allow nebulized mist tobe breathed into through the nostrils of an infant 111 while using thepacifier mist delivery device 120. The channel connects to an accesspoint 122, which is connected to the thermal nebulizing system 20through a tube 34, the connector 37 or directly to the access tube 52.

FIG. 16 shows the thermal nebulizing system 20 with an attachedcorrugated tube 60 being used on a patient. The corrugated tube 60 ispreferable attached to a T or Y shaped connector 32, opposite the endwhere a patient 111 interfaces with the thermal nebulizing system 20.The corrugated tube acts as a reservoir to collect various dropletscontained in the mist, as well as an exhalation point and a point forair to mix with the nebulized mist for inhalation. The corrugated tubemay be bent and attached to the connector 32 in order to allow for moreeffective catching of debris and mist droplets. When bent, thecorrugated tube 60 may bend to about 180 degrees, though other bends maybe desirable. When bent, the corrugated tube 60 is generally attached tothe connector 32 at the attachment point 64 through any suitableattachment mechanism 66, such a twist tie or cable tie.

FIG. 17 shows the thermal nebulizing system 20 of FIG. 16, in which apatient interfaces with the corrugate tube 60 to obtain the nebulizedmist. The port on the opposite end of the connector 32 may optionally beplugged or covered by any suitable covering mechanism 68, such as withtape, a patient's hand or finger, or the cover 36 (see FIG. 1) may beused. Alternatively, the port on the opposite side of connector 32 maybe left open. The corrugated tube 60 serves as a collection device,retaining any large droplets in the nebulized mist to prevent thepatient from inhaling these droplets. The corrugated tube 60 can also beused to direct the flow of the mist.

The chilled mist has a number of therapeutic properties, including fastacting therapy to initiate Therapeutic Hypothermia, treatment ofmultiple respiratory illnesses such as croup, laryngobronchitis, andothers, and can produce a more comfortable nebulized mist for patientswho regularly use a nebulizer. The thermal nebulizing system 20 isparticularly beneficial to emergency medical professionals: allowingearlier initiation of Therapeutic Hypothermia with the potential todrastically improve patient outcomes in cases of cardiac arrest, anoxicencephalopathy and others.

Traditionally, a number of techniques may be used to induce hypothermia,such as cooling pads, intravenous devices and intranasal wands, however,these devices are generally not used until the patient is already at ahospital or other medical facility. The thermal nebulizing system 20, onthe other hand, is capable of initiating Therapeutic Hypothermia in amobile setting, allowing first responders to use the system 20 in orderto begin life saving techniques much earlier. The thermal nebulizingsystem 20 also is simple enough for home use or use by medicalprofessionals without costly and time consuming training. Furthermore,the simple design of the system allows for low costs, and thereby allowsthe system to be treated as a one-time use system if desired in order toimprove health and safety of the system.

As will be readily appreciated from the foregoing, the device and systemof the present disclosure provides a rapid, simple method to deliverchilled oxygen, mist or medication to treat, improve or reverse symptomsrelated to the respiratory system, heat related illness, and initiationof Therapeutic Hypothermia to alleviate illness and suffering.

It is widely accepted medical practice that the application of ice toinjured tissue reduces swelling, inflammation and pain. There have beenmany attempts in the past to apply this practice to the respiratorysystem. The disclosed thermal material nebulizing system is portable andrequires no electrical connection to initiate cooling once a thermalmedium is chosen for the application. This thermal material nebulizingsystem does not require effort from the patient to initiate the mist asit is a continuous flow until the airflow is disconnected.

The historical development of Therapeutic Hypothermia (TH) dates backmillennia, and has been actively used by “modern” clinical medicine forthe last two hundred years. Routine use of TH has been employed in theOperating Room for the past fifty years. Numerous clinical trials haveused TH to reduce the core body temperature to 32-34 degrees C. Earlyrecognition of the need for TH and the rapid initiation of TH haveimproved both chances of survival and neurological outcome. Current THtreatment involves various methods to cool a patient's core temperatureof 32-34 degrees C. within four hours of insult to reduce the risk oftissue damage following a period of insufficient blood flow eitherwithin the brain or the myocardium (heart attack), or throughout thebody as a result of cardiac arrest. Multiple invasive methods arecurrently in use to maintain the core temperature within the designatedrange for approximately twenty-four hours.

The American Heart Association has released guidelines indicatingTherapeutic Hypothermia as a Class 1 evidence for surviving STEMI (heartattack), plus cardiac arrest. Targeted Temperature Management is nowrecognized as a valid treatment for other Hyperthermia related illnesslike Malignant Hyperthermia, Heatstroke and Febrile Sepsis.

The missing link in the chain of survival for patients needing rapidcooling has been the lack of a noninvasive portable inexpensive devicethat can deliver cooling to the core circulation via the respiratorysystem. The disclosed noninvasive thermal material nebulizing system isfor single patient use. The ergonomic, light weight easy use design canbe used to deliver chilled mist to adults, children, infants, newbornsand animals with beaks, trunks, or snouts for cooling via mask, mouthpiece, pacifier mist delivery device (for infants), Aerosol DeliveryHood/Tent, Endotracheal tube, Blow-by and Bipap (noninvasiveventilation).

Various types of insulators have been tested including but not limitedto Neoprene, Foil backed bubble wrap, plastic bubble wrap, Thermalevaporative material, foam.

Venues of Application and Use

Chilled mist via the disclosed thermal material nebulizing system can beused:

-   -   In any venue with a supply of compressed oxygen, air or        accessible portable nebulizer compressor to treat Epiglottis,        Croup, RSV, Bronchospasm, Fever, Allergic Reaction, Smoke        Inhalation, Blast Injury, Asthma, Bronchitis, Pneumonia,        Laryngitis, Sepsis, COPD, ventilated patients, and pre and post        ENT surgery.    -   In any venue with a supply of compressed oxygen, air or        accessible portable nebulizer compressor.    -   To initiate core cooling during CPR.    -   To initiate Therapeutic Hypothermia in any venue.    -   As an adjunct during Targeted Temperature Management.    -   By Paramedics/Flight Nurses/Military medics to initiate        Therapeutic Hypothermia post Cardiac Arrest.    -   In Emergency Departments, Intensive Care Units, Coronary Care        Units, Critical Care Units and Operating Rooms to initiate or        continue Therapeutic Hypothermia post Cardiac Arrest.    -   By Paramedics, Military and Emergency Department medical        personnel immediately upon recognition of myocardial infarction        to initiate Therapeutic Hypothermia prior to re-vascularization        in the Cardiac Catheterization Lab.    -   By Pre-Hospital, EMS Paramedic/Firefighters/Flight        Nurses/Military Medic, emergently treating Croup, RSV,        Epiglottitis, Allergic Reactions, Bronchospasm, Laryngitis,        Pneumonia, Asthma, COPD, Bronchitis, Heat Stroke and other heat        related illness, heat/blast/smoke/exposure injury/inhalation,        Sepsis and other airway compromising conditions.    -   By Emergency Department Personnel emergently treating Croup,        RSV, Epiglottitis, Allergic Reactions, Bronchospasm, Laryngitis,        Pneumonia, Asthma, COPD, Bronchitis, Heat Stroke, heat/blast        inhalation/exposure/injury, other heat related illnesses        (chemically induced hyperthermia), Sepsis and other airway        compromising conditions.    -   In the Neurological ICU to initiate Therapeutic Hypothermia post        Cerebral Vascular Accident and other Neurologic Hyperthermia        related events.    -   In the ENT postoperative setting to chill the mouth, nasopharynx        and upper respiratory tract to decrease bleeding, swelling and        to aid in pain control.    -   To initiate tissue chilling by EMS, Emergency Department,        Military medical and Wilderness Medical personnel for facial        trauma to reduce nasopharyngeal and oral swelling and to aid in        pain control.    -   By Anesthesiology in the Operating rooms and ICU's to treat        Anesthesia induced Hyperthermia by delivering chilled        mist/medication/oxygen/air to the patients core via endotracheal        tube, tracheotomy tube via Triple port nebulizer T-connector,        mask, or mouth piece to initiate Therapeutic Hypothermia.    -   By the patient at home for the treatment of Croup, Bronchitis,        Asthma, COPD and other airway compromising illnesses.    -   To connect to endotracheal (32) or tracheotomy tubes to initiate        Therapeutic Hypothermia by delivering chilled        mist/medication/oxygen/air to the patient's core.    -   On airplanes, trains, and cruise ships.    -   On space shuttle and space stations.    -   By Pre-Hospital EMS Paramedics, Firefighters and/or        Veterinarians emergently treating Animal airway compromise due        to heat/smoke/inhalation/exposure or heat related illness via        the Animal Rescue Mask.    -   By Veterinarians in animal hospitals, clinics, zoos, and        outpatient settings in treating asthma, allergic reaction and        other airway compromising illnesses via the Animal Rescue mask.

The various embodiments described above can be combined to providefurther embodiments. Aspects of the embodiments can be modified, ifnecessary to employ concepts of the various patents, applications andpublications to provide yet further embodiments. For example, FIGS. 19and 20 illustrate a double-walled configuration of a container 80 inwhich an inner wall 82 is integrally formed with an out wall 84. Thisdesign creates an air space 86 between the two walls 82, 84. Inaccordance with one aspect of the present disclosure the air space 86serves to insulate the interior of the container. Not only does thisconfiguration maintain the cool temperature within the container 80, itallows the user to hold the outer wall 84 for a prolonged period oftime. Alternatively, the air space can contain the thermal material,either as an integrated part of the container as described above or as arefillable space through an opening in the outer wall 84.

These and other changes can be made to the embodiments in light of theabove-detailed description. In general, in the following claims, theterms used should not be construed to limit the claims to the specificembodiments disclosed in the specification and the claims, but should beconstrued to include all possible embodiments along with the full scopeof equivalents to which such claims are entitled. Accordingly, theclaims are not limited by the disclosure.

The invention claimed is:
 1. A portable nebulizing device for use with athermal cooling material, the portable nebulizing device comprising: aportable container having a side wall, a bottom wall, an interior, anopen top in communication with the interior, and an input port; anebulizer sized and shaped to be located in the interior of the portablecontainer, the nebulizer including a housing having an opening, a top tocover the opening, a bottom, and an interior space, the housing having afluid input in fluid communication with the interior space andcoupleable to the input port of the portable container, and the tophaving a fluid output to be in fluid communication with the interiorspace; a lid sized and shaped to cover the open top of the portablecontainer and enclose the nebulizer in the interior of the portablecontainer, wherein the lid is configured to hold the thermal coolingmaterial to surround the nebulizer from the bottom to the top thereofwithin the interior of the portable container; a conduit to be coupledto the fluid output of the top of the nebulizer and to pass through thelid of the portable container and further to provide fluid communicationfrom the interior space of the nebulizer through the lid.
 2. The deviceof claim 1, wherein the bottom wall of the container is concave andincludes a plurality of radially oriented ridges.
 3. The device of claim1, wherein the lid has a two-tiered convex dome shape.
 4. A system thatgenerates a chilled mist from a liquid, comprising: a thermal coolingmaterial configured to chill the liquid; a nebulizing device having ahousing with an opening, a removable top to cover the opening, and abottom that define an interior space to retain the liquid, the bottomhaving a fluid input in fluid communication with the interior space, andthe top having a fluid output in fluid communication with the interiorspace; a hand-holdable container having an open top, a removable topsized and shaped to cover the open top, and an interior sized and shapedto enclose the nebulizing device, wherein the removable top isconfigured to hold the thermal cooling material to surround thenebulizer from the bottom to the top thereof within the interior of thehand-holdable container; a source of pressurized gas coupleable to thefluid input of the nebulizing device; a delivery apparatus coupleable tothe fluid output of the nebulizing device; and a conduit extendingthrough the container and into the interior of the container, theconduit coupled to the fluid input of the nebulizing device and sizedand shaped to convey pressurized gas from the source of pressurized gasto the fluid input of the nebulizing device.
 5. The system of claim 4wherein the thermal cooling material is an evaporative material.
 6. Thesystem of claim 4, wherein the conduit is sized and shaped to hold thenebulizing device above the bottom wall of the container and permit thethermal cooling material to surround the bottom of the nebulizing deviceand extend to the top of the nebulizing device.
 7. The system of claim 4wherein the delivery apparatus includes a mask having a body with aninterior chamber and a cap with radially oriented flaps that are capableof bending inward into the interior chamber, the interior chamber sizedand shaped to accommodate a muzzle, snout or beak of an animal.
 8. Thesystem of claim 4 wherein the delivery apparatus comprises: a T-shapedconnector having an input port and first and second output ports, theinput port coupled to the fluid output of the nebulizing device top; anda delivery device coupled to the first output port that is capable ofdelivering chilled mist to a recipient's mouth or nose.
 9. A nebulizingand delivery apparatus, comprising: a nebulizer having a housing with agas input and a fluid output, the housing having an opening, a removabletop to cover the opening, a bottom, an interior space, and the removabletop having the fluid output in fluid communication with the interiorspace; a hand-holdable portable container having a bottom wall, a sidewall, an interior, an input port, and an open top, the interior sizedand shaped to enclose the nebulizer; a removable cover sized and shapedto close the open top of the container, the removable cover having anopening, wherein the removable cover is configured to hold a thermalcooling material to surround the nebulizer from the bottom to the topthereof within the interior of the hand-holdable portable container; afirst conduit mounted in the opening of the removable cover and coupledto the fluid output of the nebulizer to deliver a chilled mist from thenebulizer to outside the container; a delivery apparatus coupled to thefirst conduit; and a second conduit extending through the input port ofthe container and into the interior of the container, the second conduitcoupled to the gas input of the nebulizer and sized to hold thenebulizer above the bottom wall of the container and enable the thermalcooling material to be located between the nebulizer and the bottom wallof the container and to cover the nebulizer from the bottom to the topof the nebulizer.
 10. The apparatus of claim 9, wherein the bottom wallof the container is concave and includes a plurality of radiallyoriented ridges, and the lid has a two-tiered convex dome shape.
 11. Theapparatus of claim 9, wherein the delivery apparatus includes a maskhaving a body with an interior chamber and a cap with radially orientedflaps that are capable of bending inward into the interior chamber, theinterior chamber sized and shaped to accommodate a muzzle, snout or beakof an animal and to deliver the chilled mist from the nebulizer to themuzzle, snout or beak of the animal.
 12. The apparatus of claim 9,wherein the delivery apparatus includes: a T-shaped connector having aninput port coupled to the first conduit and further including at leastone output port; and a delivery device coupled to the at least oneoutput port that is capable of delivering chilled mist to therecipient's mouth or nose.
 13. The apparatus of claim 9 wherein thecontainer includes a double-walled portion having an interior space tohold thermal cooling material.
 14. The apparatus of claim 9 wherein thesecond conduit is sized to hold the nebulizer above the bottom wall ofthe container and enable the thermal cooling material to be locatedbetween the nebulizer and the bottom wall of the container and to coverthe nebulizer from the bottom to the top of the nebulizer.